MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM

Model Number DIMENSION® EXL¿ 200

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

A united states customer contacted the siemens remote services center (rsc) on (b)(6)2022 and stated that they had washed and reused the hm reaction vessels for testing patient samples.The siemens rsc representative informed the customer that this was a non-standard use.The customer stated that on (b)(6) 2022 they decided to send out patient samples for loci high sensitivity troponin i (tnih) testing to an alternate facility.The customer stated that this resulted in a delay of approximately 14 hours.Siemens headquarters support center completed the investigation of the event.Hsc- headquarter support center reviewed the information provided.The dimension exl with lm/ dimension exl 200 operator's guide chapter 2- system operation- adding /discarding reaction vessels states- "warning: do not reuse reaction vessels." the customer is no longer reusing and washing the hm reaction vessels.The customer has received stock of dimension hm reaction vessels.The cause of the event, an apparant delay after the customer was informed of the non-standard practice, is use error.The customer is operational.A potential product issue has not been identified.The device is performing within specifications.No further evaluation is required.

Event Description

A delay in testing patient samples for loci high-sensitivity troponin i (tnih) on a dimension exl 200 system occurred after the customer was informed by siemens that their practice of washing and reusing hm reaction vessels was a non-standard use.The customer sent out samples for troponin testing to an alternate facility.There are no reports of treatment delays, patient intervention or adverse health consequences to patients due to the delay in testing tnih.

• Brand Name: DIMENSION®
• Type of Device: DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC. BROOKFIELD; registration number 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: james morgera ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 14120479
• MDR Text Key: 289985657
• Report Number: 2517506-2022-00083
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414593579
• UDI-Public: 00630414593579
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION® EXL¿ 200
• Device Catalogue Number: SMN 10636929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1